APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light Based Platform, the three models have the same intended use. They can be used in dermatology, cosmetic medicine, and other surgical applications according to the different handpieces.

The specific indications should reference to the indications of each handpiece.

Er:YAG laser handpiece:

Incision, excision, ablation, vaporization of soft tissue .
The non-ablative treatment of facial wrinkles -

Long Pulse Nd:YAG Laser Handpiece:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment . of PFB.
1. Q-Switch Nd:YAG Laser Handpiece: Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Skin resurfacing procedures for the treatment of acne scars and wrinkles
1. IPL Handpiece:

The Intense Pulsed Light wavelengths are 515-1200 nm

HR (Hair Removal): 650-1200 nm

The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles

SR (Skin Remove): 570-1200nm

The treatment of benign pigmente (epidermal and cutaneous) lesions, such as warts.

VR (Vascular and Pigmented Lesion Removal): 515-1200nm

The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, polkiloderma of civate; leg veins, and venous malformations.

Device Description

APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light. Based Platform, the three models have the same modules and handpieces. The equipment configuration is the only difference among the three models.

APOLLO V+ Medical Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The APOLLO V+ Medical Platform has three laser handpieces of Er: YAG laser, Long Pulse Nd: YAG Laser, and Q-Switch Nd: YAG Laser, and one IPL handpiece.

APOLLO IV+ Medical Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The APOLLO IV+ Medical Platform has three laser handpieces of Er: YAG laser, Long Pulse Nd: YAG Laser, and Q-Switch Nd:YAG Laser, and one IPL handpiece. There is one difference between APOLLO IV+ Medical Platform and APOLLO V+ Medical Platform, it is "desktop" style for APOLLO IV+ Medical Platform, and a standard case, with wheels to allow easy movement on the floor, for APOLLO V+ Medical Platform.

Nice Station Light Based Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The Nice Station Light Based Platform has three laser handpieces of Er:YAG laser, Long Pulse Nd:YAG Laser, and Q-Switch Nd: YAG Laser, and one IPL handpiece. The Nice Station Light Based Platform has a standard case, with wheels to allow easy movement on the floor. The difference between Nice Station Light Based Platform and APOLLO V+ Medical Platform is the appearance.

The user can activate laser emission, IPL emission by means of a footswitch.

APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light Based Platform includes:

a) Power supply
The system provides energy for the operation of equipment.

b) Control system
The system controls the cooling system, Laser emission and delivery system and safety features according the setting parameter which is set by user via the user interface.

c) User interface
User sets treatment parameter via the user interface.

d) Cooling system,
The cooling system consists of whole device cooling and IPL handpiece skin cooling.

e) Laser emission and delivery system

f) Safety features
The safety features are used to ensure the equipments is operated properly, such as key switch, -- emergency stop switch and interlock control unit.

g) Many handpiece types

Er: YAG handpiece, 2940 nm wavelength t
. Long Pulse Nd: YAG laser handpiece, 1064 nm wavelength
. Q-Switch Nd: YAG laser handpiece, 1064 nm wavelength
IPL handpiece. 650-1200nm wavelengths in RH filter, 570-1200nm wavelengths in SR filter, 515-1200 nm wavelengths in VR filter.

All of the housing of handpieces are made of ABS (Acrylonitrile Butadiene Stryene), These handpieces can be removed by the user and interchanged.

The principle of generation and treatment of energy sources

There are three kinds of energy sources, laser energy, IPL energy

The principle of generation and treatment of laser energy .
In laser handpiece, there is one optical cavity containing the laser crystal (such as Er. Y AG crystal,

Nd:YAG crystal). The laser beam is activated by means of the use of Xenon lamps.
This beam is directed to the treatment zone by means of a laser viewfinder. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

The principle of generation and treatment of IPL energy
In IPL module, the IPL (Intense Pulsed Light) which is activated by means of the use of Xenon lamp is directed to the treatment zone via the sapphire in selectable wavelengths. The IPL works on the principle of selective photothermolysis. That is, causing thermal damage to target tissue by using light of appropriate wavelength. The IPL is different from lasers in that it has many wavelengths in each pulse of light instead of just one wavelength. There are three filtered light guide for the selection of the wavelengths range.

AI/ML Overview

The provided text describes a medical device, the APOLLO V+ Medical Platform and its variants, and seeks to establish its substantial equivalence to predicate devices through non-clinical testing. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically understood for AI/ML-based medical devices.

The document is a 510(k) summary for a laser and IPL platform, which is a hardware-based device, not an AI/ML software. Therefore, the questions related to clinical performance metrics like sensitivity, specificity, reader studies, ground truth establishment, sample sizes for test/training sets, and expert consensus for AI/ML algorithms are not applicable to the content provided.

The text focuses on hardware safety, performance specifications, and biocompatibility, comparing the new device to existing predicate devices to demonstrate "Substantial Equivalence" for regulatory approval.

Here's a breakdown of what is available and why the requested information isn't present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit from testing): The non-clinical tests were conducted to verify that the proposed device met "all design specifications" and was "Substantially Equivalent (SE) to the predicate device." Implicit acceptance criteria are compliance with various international standards for medical electrical equipment safety, laser product safety, electromagnetic compatibility, and biocompatibility.
Reported Device Performance:
- Same output energy, pulse width, repetition rate, and spot size as the predicate device for laser and IPL handpieces.
- Compliance with IEC 60825-1: 2007 (Safety of laser products).
- Compliance with IEC 60601-2-22: 1995 (Safety of diagnostic and therapeutic laser equipment).
- Compliance with IEC 60601-1:1988+A1:1991+A2:1995 (General requirements for safety).
- Compliance with IEC60601-1-2:2001+A1:2004 (Electromagnetic compatibility).
- Compliance with ISO 10993-5:2009 (Biocompatibility - Vitro cytotoxicity).
- Compliance with ISO 10993-10:2002 (Biocompatibility - Irritation and delay-type hypersensitivity).
- The focusing device (viewfinder) was tested for biocompatibility and deemed not to raise safety and effectiveness problems.
- The IPL handpiece cooling method, while different from the predicate, complies with IEC 60601-1 and achieves equivalent cooling.
- Power calibration and disinfection methods are proven safe and effective via test reports.

2. Sample size used for the test set and the data provenance:

Not applicable as this is a hardware device. The "test set" would be the device itself and its components undergoing bench testing according to engineering standards. There is no patient data involved in this type of submission for demonstrating substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) is not relevant here. The "ground truth" is adherence to engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in clinical studies, which is not part of this technical hardware submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a hardware device; no AI component or human-in-the-loop performance study is described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. There is no algorithm described in the context of standalone performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for this device is its adherence to specified engineering parameters and its compliance with recognized international safety and performance standards.

8. The sample size for the training set:

Not applicable. There is no AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Section III 510(k) Summary

Project #: MIDLINK0382010Bd

Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

1. Date of Submission: Apr 15, 2011
1. Sponsor

· Beijing Syntech Laser Co., Ltd.

5F, No.1 Building, No.65 Jiancaicheng West Road, Xisanqi, Haidian District, Beijing, 100096, P.R.China Contact Person: Jin Jinghua

Position: Vice general manager

Tel: +86-10-82939866-234

Fax: +86-10-82935528

Email: sales@syntechlaser.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
1. Proposed Device Identification
  Proposed Device Name: APOLLO V+ Medical Piatform Proposed Device Model: MLP-01 Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: General& Plastic Surgery

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Project #: MIDLINK0382010Bd

Proposed Device Name: APOLLO IV+ Medical Platform Proposed Device Model: MLP-02 Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: General& Plastic Surgery

Proposed Device Name: Nice Station Light Based Platform Proposed Device Model: MLP-04 Product Code: GEX Regulation Number: 21CFR 878.4810 Review Panel: General& Plastic Surgery

Intended Use Statement:

The specific indications should reference to the indications of each handpiece.

1. Er:YAG laser handpiece:
Incision, excision, ablation, vaporization of soft tissue .
The non-ablative treatment of facial wrinkles -

Long Pulse Nd:YAG Laser Handpiece:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment . of PFB.
1. Q-Switch Nd:YAG Laser Handpiece: Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Skin resurfacing procedures for the treatment of acne scars and wrinkles
1. IPL Handpiece:

The Intense Pulsed Light wavelengths are 515-1200 nm

HR (Hair Removal): 650-1200 nm

The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles

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SR (Skin Remove): 570-1200nm

The treatment of benign pigmente (epidermal and cutaneous) lesions, such as warts.

VR (Vascular and Pigmented Lesion Removal): 515-1200nm

{3}------------------------------------------------

...... ・・・・

Predicate Device Identification 5.
- a. ER:YAG Laser Hanpiece K080374/ Bios Italia s.r.l/ BIOSYAG MEDICAL SYSTEM
- b. Long Pulse Nd: Yag Laser Hanpiece K072564/ Alma Laser, Ltd / Harmony XL Multiple Application Plateform
- Q-Switch Nd: Yag Laser Hanpiece c. K.072564/ Alma Laser, Ltd / Harmony XL Multiple Application Plateform
- d. IPL Laser Hanpiece K024093/ Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems/ Lumenis, Inc.

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Device Description 6.

. APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light. Based Platform, the three models have the same modules and handpieces. The equipment configuration is the only difference among the three models.

The user can activate laser emission, IPL emission by means of a footswitch.

APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light Based Platform includes:

a) Power supply
The system provides energy for the operation of equipment.
b) Control system
The system controls the cooling system, Laser emission and delivery system and safety features according the setting parameter which is set by user via the user interface.
c) User interface
.

User sets treatment parameter via the user interface.

d) Cooling system,
The cooling system consists of whole device cooling and IPL handpiece skin cooling.
Laser emission and delivery system e)
111-2

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Project #: MIDLINK0382010Bd

f) Safety features
The safety features are used to ensure the equipments is operated properly, such as key switch, -- emergency stop switch and interlock control unit.
g) Many handpiece types
Er: YAG handpiece, 2940 nm wavelength t
. Long Pulse Nd: YAG laser handpiece, 1064 nm wavelength
. Q-Switch Nd: YAG laser handpiece, 1064 nm wavelength
IPL handpiece. 650-1200nm wavelengths in RH filter, 570-1200nm wavelengths in SR filter, 515-1200 nm wavelengths in VR filter.

All of the housing of handpieces are made of ABS (Acrylonitrile Butadiene Stryene), These handpieces can be removed by the user and interchanged.

The principle of generation and treatment of energy sources

There are three kinds of energy sources, laser energy, IPL energy

The principle of generation and treatment of laser energy .
In laser handpiece, there is one optical cavity containing the laser crystal (such as Er. Y AG crystal,
Nd:YAG crystal). The laser beam is activated by means of the use of Xenon lamps.
This beam is directed to the treatment zone by means of a laser viewfinder. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.
The principle of generation and treatment of IPL energy
In IPL module, the IPL (Intense Pulsed Light) which is activated by means of the use of Xenon lamp is directed to the treatment zone via the sapphire in selectable wavelengths. The IPL works on the principle of selective photothermolysis. That is, causing thermal damage to target tissue by using light of appropriate wavelength. The IPL is different from lasers in that it has many wavelengths in each pulse of light instead of just one wavelength. There are three filtered light guide for the selection of the wavelengths range.
1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
. IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification, requirements.
IEC 60601-2-22: 1995, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
. IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment - Partl: General requirements for safety.
IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment - Part 1: General requirements for III-Q

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safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.

. ISO 10993-5:2009 Biocompatibility Evaluation of Medical Device, Part 5- Tests for Vitro cytotoxicity.
ISO 10993-10:2002 Biocompatibility Evaluation of Medical Device, Part 10- Test for irritation and delay-type hypersensitivity.

8. Substantially Equivalent Conclusion

About Laser handpiece and IPL handpiece, the subject device and the predicate device have the same output energy, pulse width, repetition rate and spot size.

The subject device does not have a aiming beam compared to the proposed device has a focusing device (viewfinder) fitted on the handpiece head instead of aiming beam, the focusing device has the same intended use as the aiming beam, and the Biocompatibility test of the viewfinder demonstrates that the focusing device (viewfinder) does not raise the problems of safety and effectiveness.

Although the cooling method for treated skin area between the subject device with IPL handpiece and the predicate devices is different, the subject device with IPL handpiece complies with IEC 60601-1. The temperature-of-IPL-handpiece-meets-the-requirements-which-are-specified-in-1EC-60601-1-The semiconductor absorbs the heat of the surrounding material to achieve the equivalent cooling effect.

We can't identify the power calibration (method and frequency) and disinfection method for the predicated devices, but we can provide test report to prove that the power calibration (method and . frequency) and disinfection method for the subject device are safe and effective.

The proposed devices have the same energy source, similar main technological characteristics and intended use as the predicate device, based on the comparison and analysis, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device

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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally.

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Underwriters Laboratories, Incorporated % Mr. Marc Mouser Engineering Leader, FDA Office Coordinator 2600 Northwest Lake Road Camas, Washington 98607-9526

December 12, 2012

Re: K113018

Trade/Device Name: APOLLO V+ Medical Platform/APOLLO IV+ Medical Platform/Nice -Station Light Based Platform

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: Class II Product Code: GEX Dated: November 26, 2012 Received: November 29, 2012

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{8}------------------------------------------------

Page 2 - Mr. Marc Mouser

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Apollo V+ Medical platform / Apollo IV+ Medical Platform / Nice Station Light Based Platform, the three models have the same intended use. They can be used in dermatology, cosmetic surgery, and other surgical applications according to the different hand pieces. The specific indications should reference to the indications of each hand piece.

Er: YAG Laser handpiece:

Incision, excision, ablation, vaporization of soft tissue

The non-ablative treatment of facial wrinkles

Long pulse Nd:YAG Laser handpiece:

Removal of unwanted hair, for stable long term or permanent hair reduction, and for treatment of PFB.

Q-Switched Nd: YAG Laser Hand piece:

1064nm wavelength

Tattoo removal: Dark ink: (Black

Nevus of Ota

Skin resurfacing procedures for the treatment of acne scars and wrinkles

IPL Handpiec

The Intense Pulse Light wavelength are

HR (Hair removal): 650-1200

V, and to effect stable long-term, or The removal of unwanted hair from skin type through selective targeting of melanin in hair permanent hair reduction in skin types I follicles.

Peter D. Rumm -S

(Division Sign-Off)

Division of Surgical Devices

510(k) Number_K113018

{10}------------------------------------------------

SR (skin remove): 570-1200nm

The treatment of benign pigmente (epidermal and coutaneous) lesions, such as warts.

VR (Vascular and Pigmented Lesions Removal

..............................................................................................................................................................................

Peter D. I

(Division Sign-Off)

Division of Surgical Devices

510(k) Number_K113018

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.